[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39044-39046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6395]


Request for Applications for New Members of the Clinical Trials 
Transformation Initiative/Food and Drug Administration Patient 
Engagement Collaborative

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; request for applications.

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SUMMARY: The Food and Drug Administration (FDA or Agency), in 
collaboration with the Clinical Trials Transformation Initiative 
(CTTI), is requesting applications of patient advocates interested in 
participating on the Patient Engagement Collaborative (PEC). The PEC is 
an ongoing, collaborative forum coordinated through the Office of 
Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office 
of the Commissioner, and is hosted by CTTI. Through the PEC, the 
patient community and regulators are able to discuss an array of topics 
regarding increasing meaningful patient engagement in medical product 
development and regulatory discussions at FDA. The activities of the 
PEC may include, but are not limited to, providing diverse perspectives 
on topics such as systematic patient engagement, transparency, and 
communication; providing considerations for implementing new strategies 
to enhance patient engagement at FDA; and proposing new models of 
collaboration in which patients and patient advocates are partners in 
non-product specific

[[Page 39045]]

aspects of the medical product development and FDA review process.

DATES: Applications submitted by 11:59 p.m. Eastern time on August 23, 
2021, will be considered for membership in the PEC. Incomplete 
applications and applications completed after the above-specified 
deadline will not be reviewed.

ADDRESSES: All applications should be submitted to FDA's Office of 
Patient Affairs in OCPP. The preferred application method is via the 
online submission system provided by CTTI, available at https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP. For those applicants 
unable to submit an application electronically, please call FDA's 
Office of Patient Affairs at 301-796-8460 to arrange for mail or 
delivery service submission. Only complete applications, as described 
under section IV of this document, will be considered.

FOR FURTHER INFORMATION CONTACT: Wendy Slavit, Office of the 
Commissioner, Office of Clinical Policy and Programs, Office of Patient 
Affairs, Food and Drug Administration, 301-796-8460, 
<a href="/cdn-cgi/l/email-protection#0a5a6b7e636f647e4f646d6b6d6f676f647e496566666b6865786b7e637c6f4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="d282b3a6bbb7bca697bcb5b3b5b7bfb7bca691bdbebeb3b0bda0b3a6bba4b792b4b6b3fcbabaa1fcb5bda4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    The CTTI is a public-private partnership cofounded by FDA and Duke 
University whose mission is to develop and drive adoption of practices 
that will increase the quality and efficiency of clinical trials. FDA 
and CTTI have long involved patients and considered patient 
perspectives in their work. Furthering the engagement of patients as 
valued partners across the medical product research and development 
continuum requires an open forum for patients and regulators to discuss 
and exchange ideas.
    The PEC is an ongoing, collaborative forum in which the patient 
community and regulators discuss an array of topics regarding 
increasing patient engagement in medical product development and 
regulatory discussions at FDA. The PEC is a joint endeavor between FDA 
and CTTI. The activities of the PEC may inform relevant FDA and CTTI 
activities. The PEC is not intended to advise or otherwise direct the 
activities of either organization, and membership will not constitute 
employment by either organization.
    The Food and Drug Administration Safety and Innovation Act (Pub. L. 
112-14), section 1137, entitled ``Patient Participation in Medical 
Product Discussions,'' added section 569C to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-8c). This provision directs the 
Secretary of Health and Human Services to ``develop and implement 
strategies to solicit the views of patients during the medical product 
development process and consider the perspectives of patients during 
regulatory discussions.'' On November 4, 2014, FDA issued a Federal 
Register notice establishing a docket (FDA-2014-N-1698) for public 
commenters to submit information related to FDA's implementation of 
this provision. Upon review of the comments received, one common theme, 
among others, included establishing an external group to provide input 
on patient engagement strategies across FDA's Centers. After 
considering the comments, FDA formed the PEC in 2018 to discuss a 
variety of patient engagement topics. This group is consistent with 
additional legislation subsequently enacted in section 3001 of the 21st 
Century Cures Act (Pub. L. 114-255) and section 605 of the FDA 
Reauthorization Act of 2017 (Pub. L. 115-52), further supporting tools 
for fostering patient participation in the regulatory process.
    The PEC currently has 16 members. To help ensure continuity in its 
activities and organizational knowledge, the PEC maintains staggered 
membership terms. As of September 2021, eight members will complete a 
term and up to eight new members will be selected. The purpose of this 
notice is to announce that the application process for up to eight new 
members of the PEC is now open, and to invite and encourage 
applications by the submission deadline for appropriately qualified 
individuals.

II. Criteria for Membership

    The PEC includes up to 16 diverse representatives of the patient 
community. Eight members from the previous application process will 
remain on the PEC. The current application process is to select up to 
eight new PEC members. Selected members will include the following: (1) 
Patients who have personal disease experience; (2) caregivers who 
support patients, such as a parent, child, partner, other family 
member, or friend, and who have personal disease experience through 
this caregiver role; and, (3) representatives from patient groups who, 
through their role in the patient group, have direct or indirect 
disease experience. Please note that for purposes of this activity, the 
term ``caregiver'' is not intended to include individuals who are 
engaged in caregiving as healthcare professionals; and the term 
``patient group'' is used herein to encompass patient advocacy 
organizations, disease advocacy organizations, voluntary health 
agencies, nonprofit research foundations, and public health 
organizations. The ultimate goal of the application and selection 
process is to identify individuals who can represent a collective 
patient voice for their patient community.
    Selection criteria include the applicant's potential to 
meaningfully contribute to the activities of the PEC, ability to 
represent and express the patient voice for his or her constituency, 
ability to work in a constructive manner with involved stakeholders, 
and understanding of the clinical research enterprise. Consideration 
will also be given to ensuring the PEC includes diverse perspectives 
and experiences, including but not limited to sociodemographic and 
disease experience diversity. PEC members are required to be residents 
of the United States and must be 18 years of age or older.
    Financial and other conflicts of interest will not necessarily make 
applicants ineligible for membership in the PEC. However, applicants 
cannot be direct employees of the medical product development industry 
or a currently registered lobbyist for an FDA-regulated industry.

III. Responsibilities and Expectations

    Working meetings of the PEC will typically be held two to four 
times per year, either in person (in the Washington DC area) or 
virtually (teleconference or webinar). Given the ongoing COVID-19 
pandemic, meetings will be conducted virtually and may resume in-person 
when it is safe to do so. Additional meetings may be organized as 
needed, and currently include monthly, 1-hour teleconferences.
    Reasonable accommodations will be made for members with special 
needs for travel or for participation in a meeting. Applications for 
PEC membership are encouraged from individuals of all racial, ethnic, 
cultural groups, sexual orientations, gender identities, with and 
without disabilities. Travel support will be provided as applicable.
    To help ensure continuity in its activities and organizational 
knowledge, the PEC will maintain staggered membership terms for patient 
community representatives. Membership terms for new members will be 2-
year appointments. Members may serve up to two terms, with the 
possibility of extensions.
    Additional responsibilities and expectations are set forth in the 
PEC Framework, which should be reviewed

[[Page 39046]]

prior to submitting an application, available at https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative.

IV. Application Process

    Any interested person may apply for membership on the PEC. To 
apply, go to https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP. 
The application process is completed online and includes answering 
questions to help determine eligibility for the PEC, demographic and 
other background questions, and four brief essay questions. Many of the 
demographic questions are optional. The brief essay questions, which 
must be answered in 500 characters or fewer (including spaces), are as 
follows:
    <bullet> Please explain why you would have an outstanding ability 
to represent and express the patient voice for the disease area(s) you 
selected above.
    <bullet> Please give a few examples of experiences that demonstrate 
your outstanding ability to work across stakeholders in the medical 
product development process.
    <bullet> Please explain how you have developed a strong 
understanding of the medical product development process.
    <bullet> Please tell us why you are interested in becoming a member 
of the PEC and how you would be able to contribute.
    Completing the application form also requires submitting: (1) A 
current, complete curriculum vitae or r[eacute]sum[eacute] that shows 
relevant activities and experience (PDF format preferred) and (2) a 
letter of endorsement (maximum 800 words) from a patient group with 
which the applicant has worked closely on activities that are relevant 
to the PEC (PDF format preferred). The letter of endorsement should 
emphasize information relevant to the criteria for membership described 
above. The letter may address topics such as the applicant's 
involvement in patient advocacy activities, experiences that stimulated 
an interest in participating in discussions about patient engagement in 
medical product development and regulatory decision making, and other 
information that may be helpful in evaluating the applicant's 
qualifications as a potential member of the PEC. Only complete 
applications submitted by the deadline (see DATES) will be reviewed.
    Additional information may be needed from applicants, including 
information relevant to understanding potential sources of conflict of 
interest, in which case applicants will be contacted directly.

    Dated: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15643 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


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